FDA product code NYV: Gastrointestinal Motility System, Capsule
NYV is the FDA product code for gastrointestinal motility system, capsule. It is a Class II device, regulated under 21 CFR 876.1725 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 5 510(k) submissions under NYV, 3 in the last five years, from 3 different applicants. The average 510(k) review took 133 days (median 90); 138 days on average over the last three years.
Definition
Used to evaluate GI motility disorders and indicated for use in evaluating patients with suspected motility disorders.
Classification
| Field | Value |
|---|---|
| Device name | Gastrointestinal Motility System, Capsule |
| Device class | Class II |
| Regulation | 21 CFR 876.1725 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for NYV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 2 | 90 |
| 2026 | 1 | 186 |
Compare with all 510(k) review times · Search every NYV clearance
Top NYV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Atmo Biosciences, Ltd. | 2 | 2026-05-22 |
| The Smartpill Corporation | 2 | 2009-10-30 |
| Anx Robotica Corporation | 1 | 2025-05-21 |
Most recent NYV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253569 | Atmo Biosciences, Ltd. | Atmo Gas Capsule System | 2026-05-22 | 186 |
| K250940 | Atmo Biosciences, Ltd. | Atmo Gas Capsule System | 2025-06-26 | 90 |
| K250493 | Anx Robotica Corporation | MotiliCap GI Monitoring System | 2025-05-21 | 90 |
| K092342 | The Smartpill Corporation | SMARTPILL GI MONITORING SYSTEM, VERSION 2.0 | 2009-10-30 | 87 |
| K053547 | The Smartpill Corporation | SMARTPILL GI MONITORING SYSTEM | 2006-07-18 | 210 |
Recalls for NYV devices
openFDA lists no recalls for product code NYV.
Frequently asked questions
What is FDA product code NYV?
NYV is the FDA product code for gastrointestinal motility system, capsule. It is a Class II device, regulated under 21 CFR 876.1725 and reviewed by the Gastroenterology and Urology panel.
What device class is NYV?
Class II, regulation 21 CFR 876.1725. Typical premarket route: 510(k).
How long does a 510(k) take for product code NYV?
Across 5 cleared submissions the average was 133 days from receipt to decision (median 90).
Which companies have the most NYV clearances?
Atmo Biosciences, Ltd. (2); The Smartpill Corporation (2); Anx Robotica Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NYV
- Run a recall and safety report across every NYV manufacturer
- Watch product code NYV for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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